Osteoarthritis of the KneePhase 2NCT01619839
A Phase 2 Study To Assess The Efficacy, Tolerability, And Safety OF NKTR-181 In Subjects With Chronic OA Knee Pain
A Phase 2 study testing NKTR-181 in people with Osteoarthritis of the Knee, run by Nektar Therapeutics at 34 sites in United States.
Trial summary
NKTR-181 is being developed as an analgesic compound for the treatment of moderate to severe chronic pain - active as a mu agonist, but with inherent molecular properties designed to provide a unique clinical profile, including most notably, reduced CNS side effects and an attenuated attractiveness as a target of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- NKTR-181
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 296 participants
- Where
- 34 sitesUnited States
- Study dates
- Jun 2012to Sep 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to give written informed consent;
- Willing and able to understand the study procedures, and comply with all study procedures;
- Females or males, age ≥ 18 years old;
- Body mass index 18-39, inclusive;
- In good general health;
- Clinical diagnosis of OA in one or both knees;
Show all 9Show fewer
- Have been on a stable regimen of pain medication for the management of OA knee pain;
- Not experiencing adequate pain relief with their current dosing regimen;
- Women of childbearing potential (WCBP) must agree to use highly effective methods of birth control. Male subjects must agree to use contraception.
Who cannot join
- Females who are pregnant or lactating;
- Known history of hypersensitivity, intolerance, or allergy to opioids;
- Diagnosed as having any chronic pain symptom that in the Investigator's opinion would interfere with the assessment of pain and other symptoms of OA;
- Presence of any medical condition that would preclude study participation in the opinion of the investigator;
- Clinically significant abnormalities of vital signs or clinical laboratory results;
- Clinically significant electrocardiographic abnormalities;
Show all 14Show fewer
- Received systemic corticosteroids within 30 days prior to signing the consent form;
- Subjects who are known or suspected to be currently abusing alcohol or drugs;
- Positive urine drug screen, or alcohol breath test during Screening Period testing;
- Positive serology for the surface antigen of Hepatitis B (HBsAg) or Hepatitis C (anti-HCV) during Screening Period testing;
- Known to be human immunodeficiency virus (HIV) positive;
- Donation of blood or plasma within 30 days prior to signing the consent form;
- Participation in another drug or biologic study within 30 days prior to signing the consent form;
- Any other reason that, in the opinion of the Investigator or Medical Monitor, would render the subject unsuitable for participation in the study.
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
United States34 sites
Investigator Site - Austin
Austin, Texas, 78705
Investigator Site - Berlin
Berlin, New Jersey, 08009
Investigator Site - Brockton
Brockton, Massachusetts, 02301
Investigator Site - Charleston
Charleston, South Carolina, 29406
Investigator Site - Cincinnati
Cincinnati, Ohio, 45219
Investigator Site - Coral Gables
Coral Gables, Florida, 33134
Investigator Site - Dallas
Dallas, Texas, 75231
Investigator Site - Duncansville
Duncansville, Pennsylvania, 16635
Investigator Site - Englewood
Englewood, New Jersey, 07631
Investigator Site - Evansville
Evansville, Indiana, 47714
Investigator Site - Fort Meyers
Fort Myers, Florida, 33916
Investigator Site - Garden Grove
Garden Grove, California, 92844
Investigator Site - Greensboro
Greensboro, North Carolina, 27410
Investigator Site - Kansas City
Kansas City, Missouri, 64114
Investigator Site - Kenosha
Kenosha, Wisconsin, 53142
Investigator Site - Las Vegas
Las Vegas, Nevada, 89102
Investigator Site - Las Vegas
Las Vegas, Nevada, 89119
Investigator Site - Louisville
Louisville, Kentucky, 40213
Investigator Site - Mobile
Mobile, Alabama, 36608
Investigator Site - Oklahoma City
Oklahoma City, Oklahoma, 73109
Investigator Site - Omaha
Omaha, Nebraska, 68134
Investigator Site - Pembroke Pines
Pembroke Pines, Florida, 33028
Investigator Site - Philadelphia
Philadelphia, Pennsylvania, 19139
Investigator Site - Salt Lake City
Salt Lake City, Utah, 84106
Investigator Site - San Antonio
San Antonio, Texas, 78205
Investigator Site - San Antonio
San Antonio, Texas, 78209
Investigator Site - San Diego
San Diego, California, 92103
Investigator Site - Tuscon
Tucson, Arizona, 85704
Investigator Site - Walnut Creek
Walnut Creek, California, 94598
Investigator Site - West Palm Beach
West Palm Beach, Florida, 33409
Investigator Site - Westlake Village
Westlake Village, California, 91361
Investigator Site - Weston
Weston, Florida, 33331
Investigator Site - Wichita
Wichita, Kansas, 67207
Investigator Site - Worcester
Worcester, Massachusetts, 01605
About this study
Official title: A Phase 2, Enriched-Enrollment, Randomized-Withdrawal, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy, Tolerability, and Safety of NKTR-181 in Opioid-Naïve Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee
NKTR-181 is being developed as an analgesic compound for the treatment of moderate to severe chronic pain - active as a mu agonist, but with inherent molecular properties designed to provide a unique clinical profile, including most notably, reduced CNS side effects and an attenuated attractiveness as a target of abuse.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- NKTR-181, Placebo
- Keywords
- Nektar, NKTR-181
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NKTR-181Drug
PlaceboDrug
Placebo dosing will be only in the double-blind randomization arm and will be identical in form to the Experimental NKTR-181
| Study group | Role | What they receive |
|---|---|---|
| 100 mg NKTR-181 | Experimental | 100 mg of NKTR-181 in tablet form, BID. Dosing to occur at Titration period up to 30 days and at Randomization period up to 24 days. Receives: Drug: NKTR-181 |
| 200 mg NKTR-181 | Experimental | 200 mg of NKTR-181 in tablet form, BID. Dosing to occur at Titration period up to 30 days and at Randomization period up to 24 days. Receives: Drug: NKTR-181 |
| 300 mg NKTR-181 | Experimental | 300 mg of NKTR-181 in tablet form, BID. Dosing to occur at Titration period up to 30 days and at Randomization period up to 24 days Receives: Drug: NKTR-181 |
| 400 mg NKTR-181 | Experimental | 400 mg of NKTR-181 in tablet form, BID. Dosing to occur at Titration period up to 30 days and at Randomization period up to 24 days Receives: Drug: NKTR-181 |
| Placebo | Placebo comparator | Placebo dosing will be only in the double-blind randomization arm and will be identical in form to the Experimental NKTR-181. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Mean Change From Baseline Pain Score to Pain Score at the End of the Double-blind Randomized Treatment Period.
The first phase of this trial involved an open-label titration period where patients were given NKTR-181 at increasing doses up to a maximum of 400 mg twice daily until adequate pain control was achieved. Patients achieving adequate pain control were then progressed to the second phase of the trial where patients were randomized in a 1:1 ratio to receive either placebo or their tolerable dose level of NKTR-181.
All efficacy data for NKTR-181 patients was combined into one group regardless of tolerable dose level. For this outcome, the subjects had to rate their worst pain intensity during the past 4 hours from 0 to 10 on an 11-point scale, where 0 represented one end of the continuum (i.e., no pain) and 10 represented the other extreme of pain intensity (i.e., worst pain imaginable).
Measured: Baseline and Visit 10 (day 69)
Secondary outcomes (1)
Time to Discontinuation During the Double-blind Randomized Treatment Period for Any Reason
The first phase of this trial involved an open-label titration period where patients were given NKTR-181 at increasing doses up to a maximum of 400 mg twice daily until adequate pain control was achieved. Patients achieving adequate pain control were then progressed to the second phase of the trial where patients were randomized in a 1:1 ratio to receive either placebo or their tolerable dose level of NKTR-181.
All efficacy data for NKTR-181 patients was combined into one group regardless of tolerable dose level.
Measured: Randomization Treatment period is 24 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionAug 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Osteoarthritis of the KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 296 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nektar Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Nektar Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01619839
- Sponsor's protocol ID
- 12-181-04
- Status last verified
- Jul 2021
- First submitted
- 12 Jun 2012
- Last updated
- 2 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Enriched-Enrollment, Randomized-Withdrawal, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy, Tolerability, and Safety of NKTR-181 in Opioid-Naïve Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT01619839
- Acronym / sponsor ID
- 12-181-04
- Conditions
- Osteoarthritis of the Knee
- Keywords
- Nektar, NKTR-181
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 296 participants (actual)
- Lead sponsor
- Nektar TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 14 Jun 2012 (estimated)
- Results
- Posted 2 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
NKTR-181 is being developed as an analgesic compound for the treatment of moderate to severe chronic pain - active as a mu agonist, but with inherent molecular properties designed to provide a unique clinical profile, including most notably, reduced CNS side effects and an attenuated attractiveness as a target of abuse.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 100 mg NKTR-181 | Experimental | Drug: NKTR-181100 mg of NKTR-181 in tablet form, BID. Dosing to occur at Titration period up to 30 days and at Randomization period up to 24 days. |
| 200 mg NKTR-181 | Experimental | Drug: NKTR-181200 mg of NKTR-181 in tablet form, BID. Dosing to occur at Titration period up to 30 days and at Randomization period up to 24 days. |
| 300 mg NKTR-181 | Experimental | Drug: NKTR-181300 mg of NKTR-181 in tablet form, BID. Dosing to occur at Titration period up to 30 days and at Randomization period up to 24 days |
| 400 mg NKTR-181 | Experimental | Drug: NKTR-181400 mg of NKTR-181 in tablet form, BID. Dosing to occur at Titration period up to 30 days and at Randomization period up to 24 days |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo dosing will be only in the double-blind randomization arm and will be identical in form to the Experimental NKTR-181. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Willing and able to give written informed consent;
- Willing and able to understand the study procedures, and comply with all study procedures;
- Females or males, age ≥ 18 years old;
- Body mass index 18-39, inclusive;
- In good general health;
Key exclusion criteria (14 listed)
- Females who are pregnant or lactating;
- Known history of hypersensitivity, intolerance, or allergy to opioids;
- Diagnosed as having any chronic pain symptom that in the Investigator's opinion would interfere with the assessment of pain and other symptoms of OA;
- Presence of any medical condition that would preclude study participation in the opinion of the investigator;
- Clinically significant abnormalities of vital signs or clinical laboratory results;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NKTR-181 | Drug | 100 mg NKTR-181, 200 mg NKTR-181, 300 mg NKTR-181, 400 mg NKTR-181 |
| PlaceboPlacebo dosing will be only in the double-blind randomization arm and will be identical in form to the Experimental NKTR-181 | Drug | Placebo |
Primary outcome
The Mean Change From Baseline Pain Score to Pain Score at the End of the Double-blind Randomized Treatment Period.
Time frame: Baseline and Visit 10 (day 69)
The first phase of this trial involved an open-label titration period where patients were given NKTR-181 at increasing doses up to a maximum of 400 mg twice daily until adequate pain control was achieved. Patients achieving adequate pain control were then progressed to the second phase of the trial where patients were randomized in a 1:1 ratio to receive either placebo or their tolerable dose level of NKTR-181. All efficacy data for NKTR-181 patients was combined into one group regardless of tolerable dose level. For this outcome, the subjects had to rate their worst pain intensity during the past 4 hours from 0 to 10 on an 11-point scale, where 0 represented one end of the continuum (i.e., no pain) and 10 represented the other extreme of pain intensity (i.e., worst pain imaginable).
1 secondary outcome
Time to Discontinuation During the Double-blind Randomized Treatment Period for Any Reason
Time frame: Randomization Treatment period is 24 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Osteoarthritis of the Knee
Recruiting
Outpatient Physiotherapy vs. mHealth Exercise and Self-Management for Knee Osteoarthritis (MOKneeTOR)
Knee Osteoarthristis
Not yet recruiting
Effects of Music During Walking on Pain and Muscle Activation in People With Chronic Pain Due to Knee Osteoarthritis
Knee Osteoarthritis
Recruiting
Radio- KO Radiotherapy for Knee Osteoarthritis Clinical Trial
Osteoarthritis, Knee
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Not yet recruiting
Effects of Low-Load Blood Flow Restriction Resistance Training With and Without Hip Abductor Strengthening in Patients With Knee Osteoarthritis.(BFR)
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Nektar Therapeutics
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NKTR-181 in people with Osteoarthritis of the Knee, run by Nektar Therapeutics at 34 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Mean Change From Baseline Pain Score to Pain Score at the End of the Double-blind Randomized Treatment Period. (time frame: Baseline and Visit 10 (day 69)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2021.